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Spago Nanomedical's Radioligand Therapy 177Lu-SN201 Advances in Phase I/IIa Trial Following Positive Safety Review

Oncology
  • Spago Nanomedical's Data Monitoring Committee recommended continuing the Tumorad-01 phase I/IIa study with radioligand therapy 177Lu-SN201 after analyzing safety data from 10 patients across three dose cohorts.
  • The study has demonstrated acceptable safety profiles across three dose levels (5, 10, and 15 MBq/kg) in patients with eight different tumor types, with side effects mainly limited to transient platelet impacts.
  • The company plans to recruit two additional patients at the highest dose level of 15 MBq/kg while continuing treatment at lower doses, targeting completion of the phase I portion in 2025.
  • This first-in-human study evaluates safety, tolerability, dosimetry, and initial efficacy of the candidate drug, with the phase I portion designed to identify optimal therapeutic dosing for subsequent efficacy-focused phases.

A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer

NCT06184035RecruitingPhase 1
Spago Nanomedical AB
Posted 11/30/2023

Biocon Receives CDSCO Approval for Liraglutide Diabetes Drug in India

Drug Approval
  • Biocon has received regulatory approval from India's Central Drugs Standard Control Organisation (CDSCO) for its diabetes drug liraglutide, marking a significant milestone for the company's pharmaceutical portfolio.
  • The approval enables Biocon to market and distribute liraglutide in the Indian market, expanding treatment options for diabetes patients in the country.
  • Following the regulatory clearance, Biocon shares have come into focus among investors, reflecting market confidence in the company's drug development capabilities.

Jade Biosciences to Present Preclinical Data on JADE101 Anti-APRIL Antibody for IgA Nephropathy at European Renal Congress

Monoclonal Antibody
  • Jade Biosciences will present new preclinical data on JADE101, an ultra-high affinity anti-APRIL monoclonal antibody, at the 62nd European Renal Association Congress in Vienna from June 4-7, 2025.
  • JADE101 is being developed for IgA nephropathy treatment and features half-life extension technology designed for dosing intervals of at least eight weeks.
  • The company expects to initiate a first-in-human clinical trial for JADE101 in the second half of 2025, targeting a chronic autoimmune kidney disease that can lead to end-stage kidney disease.

Nutriband Advances AVERSA Fentanyl Abuse-Deterrent Patch Development with Kindeva Partnership

  • Nutriband Inc. has formalized an exclusive product development partnership with Kindeva Drug Delivery to advance its AVERSA Fentanyl abuse-deterrent transdermal patch toward regulatory approval.
  • AVERSA Fentanyl is positioned to become the world's first abuse-deterrent opioid patch designed to prevent abuse, misuse, and accidental exposure of transdermal fentanyl patches.
  • The innovative patch technology has the potential to reach peak annual US sales of $80 million to $200 million according to market analysis.
  • The partnership involves shared development costs in exchange for milestone payments, enabling Nutriband to progress toward NDA filing and commercialization.

SpyGlass Pharma Secures $75 Million Series D to Advance Long-Term Glaucoma Drug Delivery Platform Through Phase III Trials

  • SpyGlass Pharma closed a $75 million Series D financing round led by Sands Capital to advance its innovative drug delivery platform for glaucoma treatment.
  • The funding will support two registrational Phase III trials beginning later this year for the company's platform designed to deliver three years of bimatoprost therapy.
  • Phase II clinical trial data demonstrated significant and sustained intraocular pressure reduction in glaucoma patients, supporting the platform's potential as a paradigm shift in eye disease treatment.
  • The company plans to present 24-month follow-up data from its first-in-human study at the American Academy of Ophthalmology meeting later this year.

Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution

NCT06120842Active, Not RecruitingPhase 1
SpyGlass Pharma, Inc.
Posted 10/13/2023

Sony, SCREEN, and VitroVo Launch High-Density MEA System Trial for Drug Discovery and Neurological Disease Research

Drug Discovery
  • Sony, SCREEN, and VitroVo have jointly developed a microelectrode array (MEA) system with approximately 237,000 electrodes that enables high-definition visualization of cellular electrical activity for drug discovery applications.
  • The system combines Sony's CMOS-MEA technology with SCREEN's measurement capabilities and VitroVo's analysis expertise to provide single-cell level observation of diseased versus healthy cells and their responses to compounds.
  • The technology offers a potential alternative to animal testing in drug development and shows particular promise for research into neurological disorders including depression, schizophrenia, ALS, and Alzheimer's disease.
  • The three companies will begin offering the system on a trial basis to corporations and research institutions to accelerate development and gather user feedback ahead of commercialization.

Terbium-161 Radioimmunotherapy Shows Superior Efficacy Against Lymphoma in Preclinical Studies

Targeted TherapyMonoclonal AntibodyOncology
  • Researchers at the Paul Scherrer Institute have developed a novel radioimmunotherapy using terbium-161 attached to CD30-targeting antibodies for lymphoma treatment.
  • The terbium-161 therapy demonstrated 2 to 43 times greater cancer cell killing efficacy compared to lutetium-177 in laboratory studies.
  • Preclinical mouse studies showed treated animals survived twice as long as controls, with some achieving complete cancer remission.
  • The therapy targets CD30 receptors present in approximately one-third of lymphoma patients and could address previously difficult-to-treat T-cell lymphomas.

Amivantamab Shows Promise in Colorectal Cancer as Phase 3 Trials Launch Following Encouraging Phase 1b/2 Results

Oncology
  • The phase 1b/2 OrigAMI-1 trial demonstrated that amivantamab monotherapy achieved a 22% objective response rate and 3.7-month median progression-free survival in advanced colorectal cancer patients.
  • Combination therapy with amivantamab plus FOLFOX or FOLFIRI showed enhanced efficacy with a 43% objective response rate and 7.4-month median progression-free survival in a smaller patient cohort.
  • Two phase 3 trials, OrigAMI-2 and OrigAMI-3, have been launched to further evaluate amivantamab versus cetuximab in metastatic colorectal cancer patients with RAS and BRAF wild-type status.
  • The bispecific antibody's trifunctional mechanism targeting EGFR and MET receptors, plus immune cell-directed activity, positions it as a potential improvement over current anti-EGFR therapies for the 50% of metastatic colorectal cancer patients eligible for treatment.

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

NCT06662786RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/18/2024

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

NCT05379595RecruitingPhase 1
Janssen Research & Development, LLC
Posted 7/29/2022

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

NCT06750094RecruitingPhase 3
Janssen Research & Development, LLC
Posted 12/12/2024

Comprehensive Biomarker and Prognostic Framework Emerges for ATTR-CM Disease Monitoring

  • Healthcare professionals now have access to a comprehensive framework for monitoring ATTR-CM progression using multiple biomarkers including NT-proBNP, troponin, and serum free light chains.
  • Disease progression can be detected through a combination of clinical indicators, cardiac imaging findings, and functional assessments including the six-minute walk test.
  • Regular monitoring involves echocardiography, cardiac MRI, and nuclear imaging alongside biomarker evaluations to track amyloid deposition and cardiac deterioration.
  • The integrated approach enables early detection of disease progression and timely therapeutic interventions to optimize patient outcomes.

FDA Grants First-Ever Authorization for AI Platform to Predict Breast Cancer Risk from Mammograms

AIPrecision Medicine
  • Clairity receives FDA De Novo authorization for CLAIRITY BREAST, the first AI platform to predict five-year breast cancer risk using routine screening mammograms alone.
  • The platform analyzes subtle imaging features invisible to the human eye to deliver validated risk scores through existing clinical infrastructures.
  • This breakthrough addresses limitations of traditional risk models that rely on age and family history, despite 85% of breast cancer patients having no family history.
  • The technology promises more equitable healthcare by overcoming biases in traditional models built primarily on European Caucasian women data.

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